Single Dose Administration of Ketamine 10, 20, 40 and 80 mg and 5 mg Solution for Infusion in 15 Healthy Subjects

NCT02494830 | Completed Phase 1 DMC

• 1 other identifier: Ketamine_03_2014
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed for descriptive pharmacokinetic characterization of ketamine and norketamine in serum, urine and feces after oral single dose administration of a new developed prolonged release tablet formulation containing 10, 20, 40 and 80 mg ketamine under fasting conditions and for descriptive pharmacokinetic characterization of ketamine and norketamine in serum, urine and feces after intravenous single dose administration of 5 mg ketamine solution for infusion within 30 min

Conditions

Healthy

Keywords

Anesthetic Drugs

Outcome Measures

Primary Outcomes (1)

• bioavailability (F)

  of ketamine

  before and 10, 20, 30, 40, 50 min and 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 12 16, 24 36, 48, 60 h after study medication

Secondary Outcomes (10)

• area under the concentrations-time curve (AUC)

  before and 10, 20, 30, 40, 50 min and 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 12 16, 24 36, 48, 60 h after study medication

• maximum concentration (Cmax) of the concentrations-time curve

  before and 10, 20, 30, 40, 50 min and 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 12 16, 24 36, 48, 60 h after study medication

• time point of maximum concentration (Tmax)

  before and 10, 20, 30, 40, 50 min and 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 12 16, 24 36, 48, 60 h after study medication

• terminal half-life (T1/2)

  before and 10, 20, 30, 40, 50 min and 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 6, 7, 8, 12 16, 24 36, 48, 60 h after study medication

• volume of distribution at steady state (Vss)

  before and 10, 20, 30, 40, 50 min and 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 h after study medication

Other Outcomes (2)

• cumulative excretion into urine (Ae,urine)

  24, 48, 72, 92 and 120 h after study medication

• cumulative excretion into feces (Ae,feces)

  24, 48, 72, 92 and 120 h after study medication

Study Arms (5)

ketamine 5 mg intravenous

EXPERIMENTAL

Drug: Ketamine

ketamine 10 mg oral

EXPERIMENTAL

Drug: Ketamine

ketamine 20 mg oral

EXPERIMENTAL

Drug: Ketamine

ketamine 40 mg oral

EXPERIMENTAL

Drug: Ketamine

ketamine 80 mg oral

EXPERIMENTAL

Drug: Ketamine

Interventions

Ketamine DRUG

Intravenous infusion of 5 mg ketamine solution, diluted in 240 ml 0.9% saline within 30 min under fasting conditions on study day 1 and oral administration of one prolonged release tablet ketamine together with 240 ml table water under fasting conditions with increased dose (10, 20, 40 and 80 mg) and at least 7 days wash-out between the study days

ketamine 10 mg oral; ketamine 20 mg oral; ketamine 40 mg oral; ketamine 5 mg intravenous; ketamine 80 mg oral

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• age: 18 - 45 years
• sex: male or female
• ethnic origin: Caucasian
• body mass index: \> 18.5 kg/m² and \< 30 kg/m²
• good health as evidenced by the results of the clinical examination, ECG, and the laboratory check-up, which will be judged by the clinical investigator not to differ in a clinically relevant way from the normal state
• heart frequency between 50 and 90 bpm
• blood pressure between 140 and 100 systolic and 90 and 60 diastolic
• written informed consent

You may not qualify if:

• hepatic and renal diseases and/or pathological findings, which might interfere with pharmacokinetics of the study medication
• existing cardiovascular or haematological diseases and/or pathological findings, which might interfere with the drug's safety, tolerability and/or pharmacokinetics (e.g. tachycardia \> 90 bpm, bradycardia \< 50 bpm, ischemic heart disease like angina pectoris instabilis or myocardial infarction in the last 6 months, hypertension \> 140/90 mm Hg)
• gastrointestinal diseases and/or pathological findings (e.g. stenoses), which might interfere with pharmacokinetics of the study medication
• hypersensitivity to the active ingredient ketamine or any of the excipients
• (pre-) eclampsia
• poor or untreated hyperthyreosis
• increased intracranial pressure
• glaucoma or perforating eye injury
• drug or alcohol dependence
• positive drug or alcohol screening
• smokers of 10 or more cigarettes (or equivalent) per day
• positive results in HIV, HBV or HCV screenings
• volunteers, who are on a diet, which could affect the pharmacokinetics of the drug
• heavy tea or coffee drinkers (more than 1L per day)
• lactation, pregnancy test positive or not performed or women of child-bearing age without safe contraception, as described on page 18, ch. 7.4.1. (Note for Guidance on Non-clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceutical (CPMP/ICH/286/95 modifications))

Sponsors & Collaborators

• University Medicine Greifswald: lead

Study Sites (1)

Department of Clinical Pharmacology, Ernst-Moritz-Arndt-University Greifswald

Greifswald, Mecklenburg-Vorpommern, 17487, Germany

Location

MeSH Terms

Interventions

Ketamine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Werner Siegmund, Prof

  Department of Clinical Pharmacology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2015
• First Posted: July 10, 2015
• Study Start: August 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: July 10, 2015

Record last verified: 2015-07

Locations

DE (1)